Eli Lilly & Co. and Amylin Pharmaceuticals, Inc. notified the FDA about four more deaths from pancreatitis among users of their diabetes drug Byetta. These four cases are in addition to two other Byetta pancreatitis deaths the FDA cited in their notice to healthcare providers last week. Byetta is an injection given twice a day to patients with Type-2 diabetes to lower their blood sugar levels. Concerns have grown recently among users and prescribers about the life threatening side effect.
On August 18, 2008, the FDA posted an alert on their website to notify doctors that the agency had received reports of at least six cases of necrotizing pancreatitis or hemorrhagic pancreatitis associated with Byetta. The FDA indicated that two of those six had died as a result of the severe cases of acute pancreatitis, and the other four were recovering. Despite this data, Eli Lily and Amylin do not believe there is any definite relationship between the drug and the deaths. The manufacturers and the FDA are in talks now for giving Byetta a "black box" warning for the risks of pancreatitis.
The first known Byetta pancreatitis lawsuit has already been filed in San Diego Superior Court on August 20, 2008. The diabetic patient was hospitalized back in December of 2007 with pancreatitis after using Byetta. The Byetta lawsuit alleges that Amylin and Eli Lily failed to test and monitor the side effects of the drug and did not issue warnings on the label about the potentially life threatening condition of pancreatitis.